Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]
研究概览
简要总结
The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 207 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers with blood chemistry values within normal ranges
- •Body mass index in a normal range
排除标准
- •Pregnancy or lactation
- •Alcohol and or drug abuse
- •Use of dietary supplements or any medications except contraceptives
- •Any known malignant, metabolic and endocrine diseases
- •Previous cardiac infarction
- •Blood pressure >140/90 mmHg
- •Resting heart rate not within 50 to 90 beats per minute
- •Participation in a clinical trial within the past 6 weeks
- •Physical activity of more than 5 h per wk
研究组 & 干预措施
Phytosomal curcumin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
干预措施: Phytosomal curcumin (Dietary Supplement)
Micellar turmeric extract
6 capsules of the formulation; dosage normalized to 207 mg curcumin
干预措施: Micellar turmeric extract (Dietary Supplement)
Turmeric oleoresin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
干预措施: Turmeric oleoresin (Dietary Supplement)
Native turmeric extract
6 capsules of native curcumin (207 mg curcumin)
干预措施: Native turmeric extract (Dietary Supplement)
Native turmeric extract with 7-9% volatile turmeric oils
6 capsules of the formulation; dosage normalized to 207 mg curcumin
干预措施: Native turmeric extract with 7-9% volatile turmeric oils (Dietary Supplement)
Turmeric extract plus mixture of phytochemicals
6 capsules of the formulation; dosage normalized to 207 mg curcumin
干预措施: Turmeric extract plus mixture of phytochemicals (Dietary Supplement)
Cyclodextrin complex of curcuminoids
6 capsules of the formulation; dosage normalized to 207 mg curcumin
干预措施: Cyclodextrin complex of curcuminoids (Dietary Supplement)
Liposomal curcumin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
干预措施: Liposomal curcumin (Dietary Supplement)
结局指标
主要结局
Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total curcumin after deconjugation with β-glucuronidase
Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total demethoxycurcumin after deconjugation with β-glucuronidase
Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total curcumin after deconjugation with β-glucuronidase
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total demethoxycurcumin after deconjugation with β-glucuronidase
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total curcumin after deconjugation with β-glucuronidase
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total demethoxycurcumin after deconjugation with β-glucuronidase
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
时间窗: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
次要结局
未报告次要终点